CN1578953A - Method for realizing registration according to industrial standard - Google Patents

Abstract

A method for achieving registration industrial standards that includes identifying a client's need (12), visiting the client (14), writing a quality procedures and quality manual (16), revisiting the client to update the quality procedures and quality manual and to assist with implementation, scheduling a pre-assessment and registration audit (22) with a quality management system registrar, updating the quality procedures and quality manual based on the pre-assessment and registration audit to ensure conformance to the applicable standard, and monitoring client status to ensure consultants are meeting client needs in an allotted time frame. The method may be tracked with scheduling and project software.

Description

Realize process registration according to industrial standard

Invention field

The present invention relates generally to quality, environment, Occupational Health and Safety and other management system field, in more detail, provide a cover process to assist a mechanism in 180 days period, to have nothing in common with each other but registration according to the following world and domestic standard is sought and realized to inter-related method by a series of, identify, approval test or examination: ISO9001:2000, ISO9001/9002:1994, QS-9000, ISO/TS16949, VDA6.1, TL9000, ISO13485, instrument and equipment (TE) replenish standard, semiconductor replenishes standard, ISO14001, AS9100, ISO/IEC17025 and OHSAS18001.

Background of invention

A unforgettable class has been given on U.S.'s industrial and commercial circles in the cut-throat competition of the eighties: do not provide the company of high quality of products and service can be prosperous, possibly can't survive.

In the nineties, up to entering 21 century, the not just quality of products ﹠ services itself has been widened in the definition of quality.This expansion comprises each aspect that products ﹠ services are provided, from being sold to delivery, to book keeping operation and after sale service.

When selecting the supplier of material, part or service, various levels of client no matter be industrial, wholesale or retail, need and wishes a kind of assurance, that is, they can obtain comprehensive high-quality.This demand can satisfy by the comprehensive approach of quality management.

" quality " this word itself is the reason of many confusions.ISO9000:2000,3.1.1 definition quality is " one group of degree that inherent characteristic meets the demands ", ISO8402:1994,2.1 are defined as " the characteristic summation of the ability of satisfied that illustrate and the implicit demand that entity had ".Reaching gratifying quality level relates to influential all activities of quality.

In order to obtain client's satisfaction, quality means suitable purpose or is suitable for.Briefly, quality is exactly to satisfy the ability of the needs of appointment.Whether the quality of product or service is good, depends on the needs that it should satisfy.For example, whether the toilet floor tile is applicable to the toilet in local shopping center, and its criterion very much not is same as the floor tile that the private home toilet is used.In like manner, the required satisfied standard of breadboard cleaning service also is different from the used standard of insurance company.

Before determining and judging quality, must understand client's needs.But these requirements are not limited only to products ﹠ services.They have contained all others of transaction, comprise price, delivery and time thereof and after sale service.

The history of quality can be traced back to cave dweller's epoch.Self-centered cave dweller is that the supplier is not to use again the person.In order to become the two, he must accurately know needs what, satisfies customer requirement, and he creates or makes those part article and become the supplier then.The methodology of this common-sense is passed on from generation to generation, and is still using so far.

Same notion also is applicable to inner supplier and client.In inside, quality also means the needed products ﹠ services that require of the satisfied regulation of timely payment.Correct and the good as-cast of making must be delivered to supporting zone by correct quantity when needing foundry goods.The mail of company must correct according to schedule sorting and delivery.

The main target of any enterprise exactly by market the goods or serve to it everyone (though be the individual, in partnership or thousands of shareholder) seek profit.

For a long time, each enterprise has adopted many different strategies to improve the prospect that they seek profit.Quality management provides tangible benefit for the client, but to company even more valuable.

Utilize quality management, company can increase income and reduce cost.Excellent quality helps company successfully to win new client.It is also most important aspect the maintenance existing client.As everyone knows, attract a new client than keeping the expense that the existing client spend is much more:, estimate to want the expense of 5 to 20 times of polyvoltine according to the difference of industry.Simultaneously, internal efficiency improves, and has further reduced cost.Poor efficiency and relevant labourer, material, machine and inventory cost have been avoided in quality management.It is the help company service call having avoided delay in payment, loaded and transported and repeat again also.

Undoubtedly, the necessity of quality management is to enterprise and industry, and consumer and economic integral body all are favourable.

Quality Expert W.Edwards Deming introduces Japan in nineteen fifty with quality concept and process, and the result has shaken global enterprise and industry.He is described as a kind of chain reaction with the achievement of quality management:

Price-increase market share-carry on business-provide more work chance-recoup capital outlay improves the quality-boost productivity-reduce cost-reduces

The prospect of quality management system or examination produces fear sometimes, and is chaotic or undue optimistic.Managers predict and lose the right of making decision, and thoroughly check the stop time of causing owing to tormenting people ground, and throughput rate reduces, paper work that pile up like a mountain and huge expense.The workpeople then often fears punishment.On the contrary, manager and workpeople look to quality management to solve all problems of company sometimes.

But quality management is not a general-purpose good medicine.It can solve some problems, but it does not have the miracle effect.It can not do aforesaid anything.

The not responsible technology decision-making of quality audit personnel, the quality management examination is not check.Though make report, manager and workpeople's paper work is appropriateness and a small amount of.The cost of quality management is less relatively, is offseted by cost savings usually.

The enterprise of today utilizes quality management as main profit strategy more and more.Quality management has become so important strategy in the relatively short time this fact proved the validity that it is special.

Summary of the invention

Fundamental purpose of the present invention just provides the timely realization of quality, environment, Occupational Health and Safety and other management system.Can make the present invention be suitable for including, but is not limited to the needs of the various standards of following standard: ISO9001:2000, ISO9001/9002:1994, QS-9000, ISO/TS16949, VDA6.1, TL9000, ISO13485, instrument and equipment (TE) replenish standard, and semiconductor replenishes standard, ISO14001, AS9100, ISO/IEC17025, OHSAS18001, other management system standard that ce mark, this Wen Wei are enumerated, and following management system standard.

Other purpose of the present invention comprises (but being not limited to): the increment aspect of identifying embodiment, after management system Pre-Evaluation or phase one examination, offer help to described mechanism, offer help to described mechanism in management system registration, evaluation, approval test, examination or subordinate phase examination back, write out management principle, handbook and the rules of the described mechanism of reflection actual practice, and as management system registration management unit or identify the coordinator of unit.

For satisfying these and other objects of the present invention and advantage, a kind of method that reaches industrial standard is provided, described method comprises: the demand of identifying the client; Call on a customer; Write pledge gauge journey and quality manual; Call on a customer once more and implement to upgrade quality rules and quality manual and to assist; Make Pre-Evaluation together and register the schedule of examination with quality management system registration management unit; Upgrade quality rules and quality manual to guarantee to meet industrial rules according to the result of Pre-Evaluation and registration examination; And the monitoring customer status satisfies client's demand to guarantee the consultant in official hour.Described method can be followed the tracks of with scheduling and project software.

These and other objects of the present invention and advantage are discussed below.Provide the accompanying drawing of graphic extension and example further to disclose and provide the preferred embodiments of the present invention.

Brief description

Fig. 1 is the block scheme of the explanation preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED

The basis of quality management is exactly the requirement of satisfying appointment according to client's needs.The most basic in other words concern will be guaranteed each key element of company exactly, no matter be technological process, rules, system or personnel, all should be suitable for providing the following: appropriate product or service; Product or service are submitted to appropriate client; Be submitted to appropriate place in the appropriate time; Submit satisfactory product or service to; Submission makes the product or the service of customer satisfaction; Suitable after sale service is provided; Answer relevant quality problems required information with the producer's responsibility; And with the price of consulting submit to above all.

Quality management all is vital for all companies.The quality management system that any company sets up depends on its current market and target market, and their quality requirements.Company should adopt feasible requirement when realizing quality management system.

For any company, improve quality and begin with four basic tacks.The first step is to adopt quality definition.This comprises and meeting the requirements, particularly requirement of client.Second step was a system of setting up the quality that satisfies described definition.This is the possibility of an energy identification error and the prevention system of eliminating wrong possibility.The 3rd step was to set up performance standard.These standards must be faultless.Defective and wrong neither inevitably also be unacceptable.The 4th step was a cost of determination.In other words by non-compliant cost (promptly because of for the first time doing not rightly, for example scrap, reprocess or lost customer etc. and the cost that takes place) and standard compliant price (promptly just guaranteeing for the first time to do correctly and the cost of generation) being compared the cost of calculated mass.

The problem of checking and preventing is the quality control of quality management system and the difference between the quality assurance.The former checks not meet that the latter attempts to prevent from not meet.The system seizure of being devoted to quality assurance occurs in not meeting in the technological process.It is desirable to, at this moment remedy easier and cost lower.On the other hand, the system of being devoted to quality control can allow and not meet by going down when technological process finishes.In case detect these problems, repairing may be just much much more difficult and expensive.

Quality standard

Various types of quality standards have been used many centuries.In Middle Ages, when beginning to unite, the artisan forms guild, and they have created standard separately, in order to be determined at the speciality in their the various technology.Aspect the client, quality standard is derived from military necessity.Almost the Britain king has just specified an officer to supervise the production of naval's warship before millennium.Approximately in the same period, another official then is responsible for the quality and the efficient of supervision terrestrial weapon and engineering.

Now, quality standard continues to be controlled by military necessity.In 1912, British government set up the quality that an office guarantees military aircraft.In the U.S., among World War II and afterwards, quality standard becomes primary thing, has set up the MILSTD series standard.These standards recent decades are the main quality standards of the vendor implementation of requirement U.S. Department of Defense always.

The quality standard of non-military character is in more recently age appearance.In the later stage seventies, along with quality concerning many transregional companys becomes most important, people clearly realize that the quality of output is directly relevant with the quality that drops into.Therefore, relying on supplier in a large number provides the major company of assembly and element to begin to formulate themselves proprietary quality standard and implement these standards in their supply base.

In Europe, slightly different process has been experienced in the enforcement of quality standard.There, the guiding of standard is come from government, rather than from private sector.For example Britain writing in 1979 BS5750, this is a cover national quality system standard.Described standard becomes the supplier to government, and particularly to military supplier's requirement, and whole influences of government and strength all are placed in private sector and promote BS5750.

Government actively encourages register of company.It has been created an Agency and has identified registration body and ratify another Agency and appoint trainer and course.Government has also published BS5750 increases understanding and the acceptance of the public to described standard.

European Union (EU) has also adopted a kind of quality system standard, EN-29000, and it is similar with BS5750 in many aspects.EN-29000 and BS5750 were the models of ISO9000, and ISO9000 adopted in 1987, in 1994 and revision in 2000.ISO9000 uses in full European Union.In the ensuing age, these three standards are the harmonious stage that arrives synonym mutually.

The International Organization for Stand (ISO) that is found in nineteen forty-six is the association of 132 national standards bodys.Member's body of representing the U.S. is American National Standards Institute (ANSI) (ANSI).

The International Organization for Stand that general headquarters are located at Geneva, Switzerland has been created the standard series of ISO 9000 quality management system, comprises ISO9001:2000, ISO9001/9002:1994, QS-9000, U.S.'s version.Exploitation ISO9000 is in order to simplify the world exchange of goods and service by the shared generally accepted quality standard of a cover.

Derive from and the ISO9000 that comes is the standard of a series of quality assurances and quality management from BS5750 and MILSTD MIL-Q-9858A.These assurances are not at product or service, but are applied to create the process of product or service.

These standards are had a mind to be designed to universal, and they can be used by any industry all over the world.Described series has been stipulated target, purpose and aim, but specified process not.

Since it was created, ISO9000 just became the structure ingredient of many other standards.Its quality management system derivatives comprises the QS-9000 of automobile Big Three, international automobile standard ISO/TS16949, German automobiles standard VDA6.1, international telecommunication standard TL9000, international airline aerospace standard AS9100, international medicine equipment standard ISO 13485, and the derivatives of two QS-9000: instrument and equipment (TE) replenish standard, and semiconductor replenishes standard.Other world and the domestic standard that make up in the mode that is similar to ISO9000 comprise EMS standard ISO 14001 calibration and test laboratory quality management system and technical qualification standard ISO/IEC17025, Occupational Health and Safety management system standard OHSAS18001, and the existing good manufacture method (CGMP) of U.S.'s food of medicine equipment and drug administration (FDA).

Quality planning

Quality planning (ISO90001:2000, key element 5.4; ISO9001/9002:1994, key element 4.2.3) usually be a contract specification, wherein the client has stipulated that supplier takes some quality measures when the contract of production product.The content of quality planning (being also referred to as control plan) can comprise inspection plan, design objective and crucial and/or main subcontractor and requirement.

After client's approval, quality planning or control plan promptly become the ingredient of contract.When formulating quality planning or control plan, should consider following activity: whether suitably identify and obtain to satisfying the required control measure of quality purpose, technological process, equipment, workholder, resource and technology, checking design; Technology; The rules of installation, maintenance and check and test activity; And any suitable document whether with the product compatibility, upgrade method and check and the measuring technology that is used for quality control in case of necessity, identify any special measurement requirement, evaluation is suitable for the checking activity of product and production run, understand also establishment criterion of acceptability file eliminating subjectivity, and keep required quality record and effectively with the enforcement that shows quality management system.

Quality planning or control plan can be made up of quality document, for example rules and working instruction, general activity that regulation must be finished and task.

File is as the basis of quality management system.This is basic to ISO9000, because it provides the objective/assess the evidence of system status.For the quality management audit crew, file also plays a key role, because it is very valuable reference resources.It has explained the policy of company, has defined authority, and has set up working regulation and working instruction and helped the employee and fulfil their work responsibility.

For quality management system, the structure image pyramid of file.Described file is divided into four layers, and is as shown in table 1.

Layer	Document instance
		Ground floor	Quality policy and handbook
The second layer	Rules
		The 3rd layer	Working instruction
The 4th layer	Quality record

Table 1

Quality manual (ground floor)

Quality manual is considered to highest file, is in the pyramidal top layer of quality management system file.It illustrates the quality policy of company and describes the quality management system of described mechanism.

In all key elements that constitute ISO 9000 quality management system, more important without any a specific mass handbook.The file service of described controlled distribution is in numerous basic purposes.It is an animated file that works that should initiatively use.

Quality manual has many functions.It is intended to create and the implementation quality management system, the target of describing mass management system and structure, show the promise of administration and supervision authorities to system, quote as the mutual contrast between quality management system and the ISO9001:2000, mutual contrast as the facility rules is quoted, and quote as the mutual contrast of audit crew and other designated parties (for example accredited personnel, investor and client).

Except the suitable part that covers ISO9000, quality manual can also comprise following project (comprising these projects usually really): company is to the summary of the promise of quality; At the quality concept of company and the simple policy statement of prestige; Brief company's profile at consumer and provider; How to implement mechanism's task statement of its quality objective about company; Dispensing inventory (controlled circulation); The reference list of mechanism's rules; And the statement of powers and responsibilities.

Rules (second layer)

Rules are time first grade files.They are called second layer file.

Rules provide about carrying out what activity in mechanism, how carrying out and who is to information such as their negative direct liabilities.

Quality manual is the file of full company, and rules then are the extension of quality manual at all departments.They are based on movable, describe the method and the practice of the various quality management system activities that are used for crossing over function or mechanism's boundary.

Rules do not need lengthy and tedious.They should write straightforward.ISO9001:2000 and ISO9001/9001:1994 stipulate that a mechanism only needs " described international standard is desired " file rules and working instruction (4.2.1c).

The effective rules that clearly defined responsibility will reduce the required training amount of new employee.As long as they just can finish the work according to described rules working.

Working instruction (the 3rd layer)

Working instruction belongs to one deck quality document down, the 3rd layer.They comprise and carry out movable operating personnel and product line worker with the support quality management system at the people who does things in the mechanism.

Rules are described a kind of activity, and working instruction explains how to go to finish the each task of stipulating in the rules.Working instruction is general normal to be finished by individual or department.They tell the step that operating personnel need carry out, work required equipment and resource, the preventive measure that should take and other required item.

Working instruction comprises and specifies, and should be detailed in necessarily to guarantee clear and definite and to meet the requirements.Because working instruction is the file of " how doing ", so they may can be revised by the specific mass handbook more continually.

Quality record (the 4th layer)

Quality record provides a), and quality requirements has reached or b) show the effectively file of the objective/assess the evidence of running of quality management system.These records can write or be stored on any data medium.Record should be kept at shielded place in order to avoid lose, damage or go bad.Quality management system answers definition record how long should preserve and discarded method.

Quality audit

In current customer-oriented global commerce environment, must carry out innovative approach to remain in the forward position of competition.Almost every activity in the mechanism can both benefit from innovative approach, comprises the technological process of monitoring product and service quality.

The effective tool that company can adopt in the mission of updating is exactly quality assurance (QA) examination.Since the beginning in quality epoch, this word of quality audit has different meanings for different people.

The purpose of examination

For many years, examination has obtained a disrepute.It is to increase the weight of punishment and discipline that described process often is considered as by employee and managerial personnel, rather than regards as and support to reduce and eliminate wrong, as to support consistance, checking and communication supplementary means.

Examination helps to reach many positive purposes.The most important thing is: examination is vital for the adaptive process of the quality management system of a mechanism of checking.

Inspection team

Examiner in chief is responsible for inspection team comprehensively, and inspection team is made up of one or more auditors.According to circumstances, inspection team should comprise the expert with speciality background.Inspection team can comprise examination start-up and observer's (allowing through the client), the personnel that stand trial, and examiner in chief.

Do not meet

According to ISO9000:2000,3.6.2 and ISO8402:1994, it is exactly not reach the regulation requirement that 2.10, one places do not meet.Do not meet and be divided into mainly with less important.Do not meet the result who can be written as any kind quality audit.When audit crew identified that a place does not meet, he or she must confirm it by objective/assess the evidence.Objective/assess the evidence is a kind of information, promptly by proving really or the Statement of Facts or the explanation of true relevant quality management system really in nature that observation, measurement, test or other means obtain.

ISO9000:2000,3.8.1, definition objective evidence are " supporting the existence of something or the data of authenticity ".ISO8402:1994,2.19, the definition objective evidence is " based on being proved to be real information by the fact of observing, measure, testing or other means obtaining ".ISO9000:2000,3.9.4, the definition objective evidence is " about examination criterion and the Statement of Facts that can verify, explanation or out of Memory ".ISO10011-1:1990,3.7, the definition objective evidence be " quality of related item or service or relevant quality system key element exist and qualitative or quantitative information, record or the explanation of the fact implemented, and they are based on observing, measure or testing also and can verify ".

Find not meet regular meeting's triggering alarm, this should not take place.Do not meet not necessarily bad thing.They have discerned the weak tendency that can develop into advantage, and indicate can improvements, can cause continuous improvement.

Do not meet and cause changing.Main not meeting is because of lacking rules or inconsistent the causing in the implementation quality system.The main quality that can have a strong impact on product or service that do not meet makes mechanism and employee that the risk that loses the client be arranged, and jeopardizes the certificate of industry or government, and/or other running of company is caused great bodily injury.

Main more incongruent examples comprise: contract or design audit are not had the literal rules; The inside examination report of the system defective of leaving over is not followed the tracks of evidence; A considerable amount of checks, measurement and testing apparatus do not have current calibration; The change of drawing or planning has many examples unofficially or without approval to carry out.

Can not obtain registration before taking the correction action all not being met.

The defective of light degree, less important not meeting is directly not influence product or service quality, or thinks those defectives of easy rectification.

Less important more incongruent examples comprise: mark has the isolated example of the drawing of undelegated design or tolerance change; Instrument surpasses the isolated example on calibration date; Correcting the evidence of action examines in incongruent report still unresolved in inside; Isolated example to the record deficiency of contract or design audit; And the file deficiency of the training experience of employee's acquisition.

Two kinds of other different not meeting also may take place: " important minority " and " unessential majority ".

" important minority " do not meet and can have a strong impact on quality, though quantity seldom.They are represented usually to safety or economic injury.These do not meet may be the problem of the continuous concern that detected long-standing problem or the personnel that stand trial specifically mention in examining in early days.

" unessential majority " do not meet often is little and a large amount of the generation, normally to a kind of three or more not meeting for a short time of requirement.These may reflect that the error of system and factor amount influence quality greatly.For unitary request, " unessential majority " can constitute main not meeting.

When technological process and quality manual or ISO9000 are inconsistent, will propose not meet.

When suitably not implementing, rules can not meet usually.This just causes the technological process poor efficiency.

Other does not mainly meet and comprises: the individual event defective in quality management system, product or service; Lacking the quality management system file meets the demands; The quality management file fails always to implement; Or a series of little not meeting, show the weakness of total quality management system in a zone or activity, gather and just had importance.

Another kind does not meet as follows for a short time: the quality management system of definition, file rules and working instruction all exist.Embodiment can be accepted on the whole, but meet that quality management system requires or file aspect little difference or deviation are arranged again.

Observation is another kind of examination classification.Observations be under existence conditions according to a kind of weakness of auditor's judgement, described weakness is worth clarification or investigation, so that improve the integrality and the validity of the quality management system of being examined.

Such as, in checking process, objective/assess the evidence is not enough to clearly determine whether the quality management system of being examined meets or against regulation requirement.Observations can become the following omen that incongruent possibility takes place, but and does not require the response of the side of standing trial.

Record does not meet

In case find not meet, must be recorded in and do not meet in the report (NCR).The auditor should guarantee not meet report accurately, simple and clear, readability.

In NCR, the auditor must list examination number or sign, inspection date, examination zone, normative reference, based on the incongruent report and the responsible auditor of statement of facts and the sign of the representative of standing trial.

After finishing, examination report must and be stood trial by the auditor and be represented both sides' signature.Can confirm like this that the side of standing trial has known not to be inconsistent and merge agree to take the correction action.Crucial is should keep clear and definite between the inspection team and the side of standing trial and constantly communication, to guarantee beyond thought thing can not to take place in closing session.

After having confirmed not meet, the examination group leader and the side of standing trial need just correction to take action date that (and any tracking measure) must finish reach an agreement.

Correct action and tracking

After finishing the quality management system examination and submitting final examination report to, the decision-making of correcting and taking precautions against action should be made by the side of standing trial.The auditor is responsible for identifying the documentary evidence that is not inconsistent the observations that merges/assess the evidence support objective with containing.

In examination and in the closing session, the auditor also should obtain the side of standing trial to incongruent affirmation.If requirement is arranged, the auditor can advise, and can set up and implement the correction action just now but only stand trial.

It is the obligation of checking process (no matter being first party (inside), second party or third party) that foundation, enforcement and the validity of assessment correction action are followed the tracks of not meeting of past.Only, just can think not meet and eliminate when correcting that action has been implemented and objective proving when effective.

Elimination does not meet the action of reason can check, not meet report and inner or outside examination from market feedback, customer complaint, administration and supervision authorities.

Correct action

There are several correction and the prevention action can be with solving the problem of not meeting.A kind of is the correction action of taking repair actions fast or short-term before implementing permanent long-term prevention action, can carry out then and there to alleviate further damage sometimes.

Long-term prevention action is intended to eliminate incongruent reason, is usually directed to the change of rules and system, owing to relate to complicated process, they often need some times to implement.

For ease of following the tracks of fully, correct and the process of prevention action the side of standing trial carefully document implementation and monitoring.

They should make brief description and they are corrected the training of action measure to affected employee, if particularly will be responsible for effective monitoring.Must guarantee has the written explanation of implementing from the correction action of zone of responsibility.If do not receive written explanation to the predetermined cut-off date, should get in touch the administration and supervision authorities of zone of responsibility and not take action so that what to be defined as.The side of standing trial should finish the second portion that does not meet account, corrects the process of action with documentary evidence.This comprises: the explanation of the correction action that is proposed by the side of standing trial; Institute takes to be used to make and does not meet not recurrent prevention action; And in two zones the signature of the side of standing trial.

Follow the tracks of

Examination is the round-robin activity.Examination result before when the scope of drafting follow-up review and plan can be used as reference and is commonly used for guide.The conclusion of initial examination also can trigger the comprehensive or small-sized examination of another time to confirm that solving specific incongruent correction action implements.

For more effective, initial examination plan can comprise that the activity of tracking solves incongruent requirement and process.

Can guarantee that these movable conclusions can be proposed by inspection team before initial examination, the announcement side of standing trial, and by the side of standing trial and client's agreement.

As previously mentioned, the auditor only is responsible for identifying and does not meet.Determining and starting the correction action then is the responsibility of the side of standing trial.

According to inspection result, the quantity of system problem particularly, or find main or do not meet to crucial minority need to formulate the calendar plan of following the tracks of examination.Current examination can only be checked and do not met and correct action, also can be comprehensive review.Follow the tracks of the necessity and the scope of examination and made decision by the client, many factors are depended in this decision, can determine by checking process.

A series of having nothing in common with each other but inter-related step need be passed through by hope reaches industrial standard in 180 days time mechanism.These steps comprise following process: determine that described mechanism implements management system and the needs of registration; Determine that relevant management system is implemented and the possibility of registration; Determine and to implement and to register resulting increment aspect from management system; Implement and these increment aspects of registration realization by management system; By suitable computer software application program (that is: database, project management, scheduler program etc.) tracking implementing process; Monitor the tracking implementing progress by general manager and consulting management device; Set up the management system policy and the handbook of described mechanism in the center; And check management system rules handbook in the center.

Now consult Fig. 1, the preferred embodiments of the present invention can comprise following one side or number aspect: identify client's needs, shown in square frame 12; The scene calls on a customer, shown in square frame 14; Write quality rules and quality manual, shown in square frame 16; Follow the tracks of and determine that file has or not any variation etc. to check by client consulting, project manager, shown in square frame 18; Shown in square frame 12; The advisory agent scene that calls on a customer once more carries out file modification and assists implementing, shown in square frame 20; The advisory agent formulates the calendar plan of Pre-Evaluation and registration examination with the quality management system Registrar, shown in square frame 22; Pre-Evaluation and registration examination back advisory agent carry out necessary further file correction to guarantee to meet the standard that is suitable for, shown in square frame 24; Project Coordinator monitoring customer status also guarantees that the advisory agent meets client's demand in the official hour framework, shown in square frame 26.

Best, step 1 to 7 is followed the tracks of with scheduling and project management software at least.

Go through these steps at following each joint.

Identify the methodology of customer demand

Customer demand is differentiated by three kinds of main channels: the representative of sales ﹠ marketing; Project Coordinator; And advisory agent.

Introduce the representative of sales ﹠ marketing to possible client by several means, comprise post assignment, internet and/or the appointment of arranging in designated geographic area.After the introduction, the representative of sales ﹠ marketing by with the needs of repeatedly briefly meeting with definite client of crucial administration and supervision authorities.

In case representative of sales ﹠ marketing and client have signed contract, Project Coordinator initially contacts.If customer demand is different with representative of sales ﹠ marketing's conclusion, it is noted and modification place is write file.

Advisory agent and trade connection then.When first on-the-spot visit, the advisory agent meets with crucial administration and supervision authorities once more, to confirm at first by representative of sales ﹠ marketing's definition and the demand being confirmed and/or revised by Project Coordinator.

By these three kinds of methods, customer demand is defined as two big classes.

The first kind is registration, evaluation, approval test or the examination according to the following world and domestic quality management system standard: ISO9001:2000, ISO9001/9002:1994, QS-9000, ISO/TS16949, VDA6.1, TL9000, ISO13485, instrument and equipment (TE) replenish standard, and semiconductor replenishes standard, ISO14001, AS9100, ISO/IEC17025 and OHSAS18001 are used for enterprise marketing, or because the result of client's pressure.

Because the promulgation of quality, environment, Occupational Health and Safety and other management system standard, subcontractor and supplier realize according to the pressure of registration, evaluation, approval test or the examination of the following world and domestic quality management system standard increasing: ISO9001:2000, ISO9001/9002:1994, QS-9000, ISO/TS16949, VDA6.1, TL9000, ISO13485, instrument and equipment (TE) replenish standard, and semiconductor replenishes standard, ISO14001, AS9100, ISO/IEC17025 and OHSAS18001.For example, if client A requires supplier B to realize according to certain International or National quality management system standards registration, evaluation, approval test or examination, then supplier B will require registration, evaluation, approval test or the examination of subcontractor C realization according to described International or National quality management system standard.So, International or National quality management system standard will be the part of the supply of material chain member supplier's that offers them requirement.Company may feel that the client wants it to realize except satisfying the client, in fact can't see set benefit according to the pressure of registration, evaluation, approval test or the examination of certain International or National quality management system standard.

In addition, registration, evaluation, approval test or the examination according to International or National quality management system standard can bring certain visible marketing interests.Key concept is registration, evaluation, approval test or the examination that International or National quality management system standard has been arranged, and its goods or service just can more effectively be sold by company.

Second class of customer demand is the increment aspect, it exceeded seek to register, the hope of evaluation, approval test or examination, its whole purposes obtain registration, evaluation, approval test or examination exactly.

Except above-mentioned one or both potential customer demands, perhaps above-mentioned various potential customer demand all is left out, and seeks may have the increment aspect that other need be differentiated according to the company of registration, evaluation, approval test or the examination of International or National quality management system standard.This decides with described company, and can differ widely between each mechanism.

A value-added example is by certain problem in the enforcement correcting mechanism of management system standard or a series of problem.They can comprise professional any aspect, and comprise that rejection rate descends, does over again, increases customer satisfaction and lasting improvement.

Value-added another example is to realize consistance in some operation of mechanism.The enforcement of management system standard usually can be used for still not existing or the improved consistance of needs for mechanism brings.

The 3rd example relate to utilize the management system standard enforcement as the instrument of discussing, it can provide the system of groupthink, original creation suggestion and team's activity, so that produce the solution to the innovation of common issue with.

The 4th example comprises owing to there being good business practice file to reduce the responsibility exposure.

Value-added another example comprises seeks to reduce total, specific and insurance money product liabilities as the result of effective management system standard implementation.

Also have another example to comprise that an inside and outside expense related with the management system standard implementation regards the direct investment of enterprise as, and calculate acceptable investment repayment.

The methodology of the on-the-spot visit of advisory agent

Except above-mentioned further revision customer demand, the advisory agent should finish following task in first visit: acquisition of information is that management system is prepared; Interview key manager and employee; Collect enough information and be the first draft of management system rules and prepare, determine the scope of registration, evaluation, approval test or examination; Estimate the time that Pre-Evaluation phase one (registration, evaluation, approval test, examination) or subordinate phase examination etc. take place.In addition, if the essential accurately qualification of Pre-Evaluation or phase one examination, then the advisory agent should or assert unit duty settled date journey plan with selected management system registration side; And carrying out first on-the-spot visit near the time of Pre-Evaluation, phase one (registration, evaluation, approval test, examination) or subordinate phase examination as far as possible.Advisory agent's visit should have the schedule that is similar to the examination plan; The beginning meeting, closing session; And the action plan that is similar to the management system standard implementation of correcting action plan.

Write policy, the methodology of rules and handbook

As the result of first visit, the advisory agent has collected essential information and has write the management system rules.The content of quality rules is based on the suitable key element of management system standard, specifically, rules at the requirement of described standard or with standard require consistent.

In addition, for any special enterprise, application management system standard can be very difficult.For the standard that is suitable for is used for special application scenario, need the basic process model of reasoning, abstract thinking and enterprise on the understanding.For all these reasons, writing rules requires the advisory agent that thorough clairvoyance is arranged.Good communication skill also is very important, because it can make the advisory agent distinguish required information from the company aspect.

Seek advice from etc. the methodology of checking by the client

Write after the draft report, file has been delivered to central source.These employees are responsible for examining handbook and other file, meet all requirements that are suitable for the management system standard to guarantee them.Experienced and consultant that trained checks file.If can not satisfy all requirements, handbook is considered to not meet standard.They are return to the advisory agent.The advisory agent carries out any necessary modifications so that the handbook conformance with standard.After handbook meets, through handling and handing to the client and check.

On-the-spot methodology once more calls on a customer

Suppose successfully register, client's motivation and leader is a crucial factor aspect evaluation, approval test or the examination.For this reason, the advisory agent is indispensable for the definition of registration, evaluation, approval test or examination.The draft copy part of management system policy, handbook and rules repeatedly is provided to company possibly.But check these files and take some times possibly.This delay is because other time-consuming affairs, shortage interest and other excuse cause.

For fear of these problems, general manager (GM) and yardman set the advisory agent and return scene, directly and client's audit document and time of carrying out necessary modification together.This shows company's requirement and facilitates file audit and modification.

Except file audit and modification, the advisory agent comes into effect suitable management system.Finally, implementing suitable management system effectively is the responsibility of company.This is reflected in the suitable key element of management system standard.But the advisory agent leads this work and the most effective technical application of demonstration at first.

Assist to formulate the methodology of Pre-Evaluation and registration examination schedule

Advisory agent and management system registration side or identification unit assist to formulate the schedule of Pre-Evaluation, phase one (registration, evaluation, approval test or examination) or subordinate phase examination together.

Except file with implement instructing, the advisory agent also is that the coordinator of management system registration side or identification unit and they formulate the schedule that Pre-Evaluation, phase one (registration, evaluation, approval test or examination) or subordinate phase are examined together.In this role, the advisory agent should guarantee to formulate the examination schedule and carry out on time, and in 180 days, realize registration, evaluation, approval test or examination.

The correspondent party science of law

Carry out necessary file correction Pre-Evaluation, phase one (registration, evaluation, approval test or examination) or subordinate phase examination back advisory agent, with the requirement of guaranteeing to meet suitable management system standard and registration side or assert unit.

As long as carry out Pre-Evaluation, phase one (registration, evaluation, approval test or examination) or subordinate phase examination must the demand file changes.File is that of suitable management system standard enlivens part, in all examinations, comprises always needing to adjust after supervision is examined.

Owing to be the file write at first of advisory agent and have higher level training aspect the management system standard being suitable for usually, so he is responsible for making amendment.The advisory agent does some training very often, special viewpoint from experience.Any examination all can be found not meet, and needs creationary solution.The extensive knowledge and experience of advisory agent can provide these solutions in the time must doing the file modification.

The methodology of track project state

All project stages are all by using scheduling and project management software to follow the tracks of.The project manager monitors customer status and guarantees that the advisory agent satisfies the customer demand of having differentiated in the official hour framework.

Because the task of assigning is all very sensitive to the time, leading and managing client importantly concerning the advisory agent.Inference advisory agent to this also must be managed and be provided the leader of mechanism.This is to realize by advisory agent's coordination personnel, project manager and project management software.Basic software is Paradox, is configured to satisfy the particular demands of report and monitoring.

Use advisory agent's coordination personnel, project manager and software can monitor advisory agent and project effectively.The most important thing is, can differentiate current and potential problem fast, and can take suitable correction and prevention action.

Though the preferred embodiments of the present invention are described, these embodiment and undeclared institute of the present invention might forms.The words and phrases that use in instructions all are descriptive and nonrestrictive, obviously, can carry out various changes and do not deviate from the spirit and scope of the present invention.

Claims (8)

1. process registration that is used to realize according to industrial standard, described method comprises:

Identification client's demand;

Visit described client;

Write quality rules and quality manual;

Visit described client once more, upgrade described quality rules and quality manual and assist and implement;

Formulate the schedule of Pre-Evaluation and registration examination together with the quality management system Registrar;

Upgrade described quality rules and quality manual to guarantee to meet described industrial standard according to the result of described Pre-Evaluation and registration examination; And

The monitoring customer status can satisfy client's demand to guarantee advisory agent in the framework at the appointed time.

2. the method for claim 1 is characterized in that: utilize scheduling and the described method of project software track.

3. the method for claim 1 is characterized in that: finished described method in 180 days.

4. the method for claim 1, it is characterized in that: described industrial standard is to select from the group that is made of following standard: ISO 9001:2000, ISO 9001/9002:1994, QS-9000, ISO/TS 16949, VDA6.1, and TL 9000, ISO 13485, instrument and equipment (TE) replenish standard, and semiconductor replenishes standard, and ISO 14001, AS 9100, ISO/IEC 17025 and OHSAS 18001.

5. process registration that is used to realize according to industrial standard, described method comprises:

The step of identification customer demand;

The step that calls on a customer;

Write the step of quality rules and quality manual;

Visit described client once more, the step of upgrading described quality rules and described quality manual and assisting to implement;

Formulate Pre-Evaluation together and register the step of examining schedule with the quality management system Registrar;

Upgrade described quality rules and quality manual to guarantee to meet the step of described industrial standard according to the result of described Pre-Evaluation and registration examination;

The monitoring customer status satisfies the step of client's demand to guarantee the advisory agent in the official hour framework.

6. method as claimed in claim 5 is characterized in that: utilize scheduling and the described method of project software track.

7. method as claimed in claim 5 is characterized in that: finished described method in 180 days.

8. method as claimed in claim 5 is characterized in that: described industrial standard is to select from the group that is made of following standard: ISO 9001:2000, ISO 9001/9002:1994, QS-9000, ISO/TS 16949, and VDA 6.1, and TL 9000, ISO 13485, instrument and equipment (TE) replenish standard, and semiconductor replenishes standard, and ISO 14001, AS 9100, ISO/IEC 17025 and OHSAS 18001.

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